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XTL Biopharmaceuticals Initiates Phase IIb Clinical Trial of Bicifadine for the Treatment of Diabetic Neuropathic Pain
Date:9/10/2007

urther evidence of the efficacy of the SNRI class in neuropathic pain.

ABOUT BICIFADINE

Bicifadine is an SNRI which is presently being developed for the treatment of diabetic neuropathic pain. As a member of the proven SNRI class, Bicifadine is expected to demonstrate efficacy in the treatment of diabetic neuropathic pain. Bicifadine has already demonstrated its efficacy as an analgesic in 15 clinical trials in patients suffering from acute pain, including in two large, randomized, placebo-controlled Phase III trials. In addition, Bicifadine has already demonstrated a favourable safety profile, having been evaluated in more than 3,000 patients.

Bicifadine is different from other approved members of the SNRI class in its unique ratio of inhibition reuptake of serotonin versus norepinephrine (which is weighted towards norepinephrine reuptake inhibition). This unique ratio is expected to translate into a unique response profile of patients to Bicifadine.

As the treatment paradigm in neuropathic pain involves switching patients among drugs (both within the same drug class, as well as among drug classes), in order to find the specific drug to which the patient responds best, Bicifadine is expected to offer a unique alternative to patients who do not adequately respond to the currently approved drugs. Furthermore, if clinical trials demonstrate that Bicifadine has an advantage over the currently approved drugs in either overall efficacy rates, safety profile, or onset of action, it has the potential to become a first-line treatment for diabetic neuropathic pain.

ABOUT XTL BIOPHARMACEUTICALS LTD.

XTL Biopharmaceuticals Ltd. ("XTL") is engaged in the development of therapeutics for the treatment of neuropathic pain and hepatitis C. XTL is developing Bicifadine, a serotonin and norepinephrine reuptake inhibitor, for the treatment of diabetic neuropathic pain. XTL is also developing several novel pre-clinical hepatitis C small molecule inhi
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